News & Events
C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem
C-Path today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the FDA Center for Devices and Radiological Health’s proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation.
The Critical Path Institute (C-Path) today announced the appointment of Klaus Romero, M.D., M.S., F.C.P., as its new Chief Science Officer (CSO) effective April 1, 2020. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years combined experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007. His most recent role has been as Executive Director of Clinical Pharmacology and Quantitative Medicine. He will continue in dual roles as CSO and head of the Quantitative Medicine Program.
The Critical Path Institute (C-Path) today announced it has named Sudhir Sivakumaran, Ph.D., as Executive Director of its Critical Path for Alzheimer’s Disease (CPAD) consortium effective immediately. Dr. Sivakumaran, a neuroscientist and research and development professional, has nearly 20 years combined experience in academic, pre-clinical and early clinical research and development, phase 1 and phase 2 clinical study design, data analysis and diligence and business development. He has been with C-Path since July 2019 as Associate Director for CPAD.
ERA4TB, an International Consortium to Accelerate the Development of Comprehensive Treatments Against Tuberculosis
C-Path, Ltd. and more than 30 partners from 13 countries participate in the ERA4TB project.
The ERA4TB (European Regimen Accelerator for Tuberculosis) project is a public-private initiative dedicated to the development of drugs against tuberculosis. With a team of more than thirty organizations and a budget of over 200 million euros ERA4TB will focus on developing a new, improved tuberculosis treatment. The partners will share their expertise, knowledge and resources to rapidly progress new candidate drugs into clinical trials.
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- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD